Quality Engineering & CSA Director: Validation & Data Integrity

Seranbio; Bend (OR); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Paid time off

Retirement plan

Health plans

Life & disability insurance

Employee assistance program

Pet insurance

Job summary

Serán BioScience seeks a Director of Quality Engineering & CSA to lead validation, qualification, and data integrity programs across GMP manufacturing and QC. You will drive risk-based validation life-cycle management, CSA adoption, and regulatory readiness, coordinating with Engineering, Manufacturing, IT, Regulatory Affairs, and Operations.

You will establish governance, KPIs, and continuous improvement initiatives to ensure validated systems remain in a validated state and support compliant

Qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• Minimum 10+ years GMP/Quality experience in pharma/biotech.
• 5+ years in qualification/validation/CSA in QA/technical roles.
• Experience with FDA/EU inspections.

Responsibilities

• Provide strategic leadership for validation, CSA, and data integrity programs across GMP operations.
• Oversee validation lifecycle docs: VMPs, URS, IQ/OQ/PQ, reports and summaries.
• Ensure compliance with FDA, EU, and GAMP guidance and data integrity requirements.
• Lead cross-functional teams in validation, qualification, and system lifecycle activities.
• Direct QA oversight for change control, deviations, CAPA, risk management and periodic reviews.
• Prepare for regulatory inspections and client audits; drive continuous improvement.

Skills

GMP Knowledge

Leadership

Regulatory Awareness

Data Integrity

Cross-functional Collaboration

Quality Assurance

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Tools

GAMP 5

CSA/CSV tools

Job description

Serán BioScience seeks a Director of Quality Engineering & CSA to lead validation, qualification, and data integrity programs across GMP manufacturing and QC. You will drive risk-based validation life-cycle management, CSA adoption, and regulatory readiness, coordinating with Engineering, Manufacturing, IT, Regulatory Affairs, and Operations.

You will establish governance, KPIs, and continuous improvement initiatives to ensure validated systems remain in a validated state and support compliant